Ethics approval
The FIDEL study was conducted in accordance with the principles of the Helsinki Declaration and its subsequent amendments and Good Clinical Practices (CPMP/ICH/135/95). It was approved by an independent French Ethics Committee (Comité de Protection des Personnes Nord Ouest IV , approval given on December 10, 2013) as required by French law19,23.
The research was also submitted to the French Regulatory Agency (Agence Nationale de Sécurité du Médicament et des produits de santé ). Authorisation was given on November 25, 2013.
Given the emergency context, consent to participate was obtained after brief delivery of information to the patient, or a relative or reliable person, depending on the patient’s level of consciousness. In all cases, as soon as possible, the patient was fully informed about the study and asked to sign a post-inclusion consent form to continue participating.
The FIDEL study was registered in the European and US trial databases under Eudract No. 2013-002484-26 and NCT02155725, respectively.